Prior to joining KARA & Associates in 2003, Korina worked for many notified bodies, as well as medical device manufacturers in regulatory affairs and quality assurance roles. She was responsible for a variety of RA/QA functions, including ensuring compliance with FDA QSRs (21 CFR Section 820), EU regulations and other international regulations. Her work included auditing, international submissions and FDA 510(k) preparations, product registrations, training, ISO implementation and CE Marking requirements. Korina holds a Bachelor’s degree in Public Relations and actively speaks on regulatory topics for various national, as well as international organizations, such as: RAPS, AMDM, SDRAM, USC, SDSU and others. Korina is a qualified training instructor for the MDR by numerous notified bodies.